RECRUITING

A Mindful Community for People With ALS and Their Primary Caregivers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The psychological impact of ALS on patients and caregivers is high, significantly affecting their quality of life (QOL). Despite this impact, there is not much research about psychological interventions that could reduce psychological distress and improve QOL. The efficacy of mindfulness-based treatments for the improvement of QOL was previously demonstrated by the investigator's group. Despite preliminary positive results, treatment efficacy tends to weaken over time. The investigators believe that a robust solution to maintain efficacy is to maximize the utilization of technology and emerging social platforms, establishing a "mindful community" to promote and continuously reinforce mindfulness. This project's primary aims are 1) to develop a "mindful" online community of people with ALS and their caregivers, and 2) to test its efficacy in QOL improvement. This two-part intervention consists of 1) optimizing the investigator's prior e-learning platform with a three-week program including cognitive exercises, videos and lectures to increase participants' mindfulness; and 2) involving participants in a "mindfulness community" within a social sharing forum. Assessments will be performed before and immediately post-treatment as well as 3- and 6-months post-program comparing subjects undergoing the intervention to a control group.

Official Title

A Mindful Community for People With ALS and Their Primary Caregivers

Quick Facts

Study Start:2023-10-12
Study Completion:2024-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05595850

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * a definite, probable, laboratory-supported, or possible ALS by revised El-Escorial criteria
  2. * they must have the physical ability, with or without adaptive devices, to use a smartphone, a tablet, or a computer
  3. * have access to the Internet.
  4. * be the person who resides with the ALS patient and is the major provider of unpaid care and assistance (typically, the spouse or another close relative)
  5. * s/he must be able to use the application
  6. * have access to the Internet.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Deborah R Phillips, PhD
CONTACT
9739027938
dphillips@fas.harvard.edu
Francesco Pagnini, PhD
CONTACT
francesco.pagnini@unicatt.it

Principal Investigator

Ellen Langer, PhD
PRINCIPAL_INVESTIGATOR
Harvard U

Study Locations (Sites)

Harvard University
Cambridge, Massachusetts, 02138
United States

Collaborators and Investigators

Sponsor: Harvard University

  • Ellen Langer, PhD, PRINCIPAL_INVESTIGATOR, Harvard U

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-12
Study Completion Date2024-07-31

Study Record Updates

Study Start Date2023-10-12
Study Completion Date2024-07-31

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness
  • Quality of Life

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis
  • Caregiver Burden